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FDA 510(k)

Bone Solutions Mixing and Delivery System

K-Number: K161568 · 2016-09-16

ApplicantBone Solutions, Inc.
Decision Date2016-09-16
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Bone Solutions Mixing and Delivery System is a medical device manufactured by Bone Solutions, Inc.. It received FDA 510(k) clearance on 2016-09-16 under approval number K161568. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bone Solutions Mixing and Delivery System?

Bone Solutions Mixing and Delivery System is a medical device that received FDA 510(k) clearance on 2016-09-16. It is manufactured by Bone Solutions, Inc.. The 510(k) number is K161568.

When was Bone Solutions Mixing and Delivery System approved by the FDA?

Bone Solutions Mixing and Delivery System received FDA 510(k) clearance on 2016-09-16, under approval number K161568.

What company makes Bone Solutions Mixing and Delivery System?

Bone Solutions Mixing and Delivery System is manufactured by Bone Solutions, Inc..

What is the FDA product code for Bone Solutions Mixing and Delivery System?

The FDA product code for Bone Solutions Mixing and Delivery System is FMF.

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Related PubMed Literature

PMID: 41813232 Artificial Intelligence Applications in Medical Devices for Personalized Health Care Solutions: Systematic Review. Journal of medical Internet research (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by Bone Solutions, Inc.

K192674Mixing and Delivery System K221256Mg OSTEOINJECT K212991Osteorevive K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™ K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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